EP1331886B1 - Closure device for tissue repair - Google Patents
Closure device for tissue repair Download PDFInfo
- Publication number
- EP1331886B1 EP1331886B1 EP01981796A EP01981796A EP1331886B1 EP 1331886 B1 EP1331886 B1 EP 1331886B1 EP 01981796 A EP01981796 A EP 01981796A EP 01981796 A EP01981796 A EP 01981796A EP 1331886 B1 EP1331886 B1 EP 1331886B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- suture
- fixation
- flexible member
- fixation member
- tissue
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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- 0 C1CC*CC1 Chemical compound C1CC*CC1 0.000 description 2
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0404—Buttons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0409—Instruments for applying suture anchors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0417—T-fasteners
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
- A61B2017/0456—Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
- A61B2017/0458—Longitudinal through hole, e.g. suture blocked by a distal suture knot
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B2017/0496—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
- A61F2/0811—Fixation devices for tendons or ligaments
Definitions
- the invention relates to a closure device for tissue repair.
- Fibrous tissue wounds such as muscle, ligament, and cartilage tears
- sutures can be repaired arthroscopically using sutures.
- a surgeon would insert two suture needles into the tissue with sutures attached, thread the sutures across the wound, and then tie knots to fix the free ends of the sutures within the tissue.
- suture anchors To simplify the wound closure procedure and to improve fixation, various types of suture anchors have been developed.
- a suture anchor is disclosed in Hayhurst, U.S. Patent No. 4,741,330 .
- one end of a suture is fixed to a resiliently-deformable, bar-shaped suture anchor.
- the anchor is loaded into the bore of a hollow needle and deployed into or against the fibrous tissue.
- the surgeon then threads the suture across the wound and tensions a free end of the suture to pull the wound closed.
- the bar in the anchor becomes oriented transversely to the suture hole, anchoring the suture in place.
- U.S. Patent No. 4,235,238 describes an apparatus for suturing coeliac tissues and has been used for the delineation in two-part form of claim 1.
- a surgical method includes positioning a fixation member relative to tissue, moving a flexible member coupled to the fixation member relative to the fixation member to bring two tissue surfaces together, and moving a retaining element coupled to the flexible member relative to the fixation member.
- the retaining element acts to limit loosening of the flexible member relative to the fixation member.
- the method enabled by the present invention may include one or more of the following features.
- the step of moving the flexible member comprises pulling the flexible member.
- the step of moving the flexible member also accomplishes the step of moving the retaining element, which is, for example, a slip knot.
- the step of moving the retaining element includes moving the retaining element relative to the flexible element.
- the retaining element is, for example, a friction element which permits sliding of the retaining element relative to the flexible element in only one direction.
- the retaining element is in the form of an overhand knot, and the method includes advancing the overhand knot along the flexible element.
- the retaining element is in the form of a Chinese trap.
- the step of moving the flexible member includes pulling on only one end of the flexible member.
- the method includes positioning a second fixation member relative to the tissue.
- the second fixation member is coupled to the flexible member, either movably or fixedly.
- the step of moving the flexible member includes, for example, pulling on two ends of the flexible member or pulling on only one end of the flexible member.
- the step of positioning the fixation member includes positioning the fixation member on an outer surface of the tissue, and the two tissue surfaces brought together are both soft tissue.
- the fixation member is positioned in a bone hole, and one of the two tissue surfaces brought together is bone and the other soft tissue.
- the step of positioning the fixation member includes passing the fixation member through a loop of the flexible member.
- the loop is positioned within a tear in soft tissue.
- the invention enables a method for repairing a tear in soft tissue includes advancing a fixation member coupled to a flexible member through tissue on either side of the tear and through a loop of the flexible member, and tensioning the flexible member to bring two tissue surfaces on either side of the tear together.
- Embodiments of this method may include one or more of the following features.
- the loop is positioned within the tear.
- the method includes pulling an end of the flexible member to bring the two tissue surfaces together.
- the fixation member is in the form of a barbed member.
- an apparatus for repairing a tear in soft tissue comprising:
- the retaining element coupled to the flexible member is slidably received by the flexible member.
- the flexible member is movably coupled to the second fixation member such that a first end of the flexible member is looped back and secured to the second flexible member to form a loop, the loop being remote from the fixation member.
- the apparatus further comprises:
- the shaft comprises a tube.
- the first and second regions comprises a groove.
- the apparatus further comprises:
- the first fixation member is positioned within the distal region before fixation on tissue and the second fixation member is positioned within the proximal region before fixation on tissue.
- one of the holding elements comprises a crimp in the needle in the distal region.
- one of the holding elements comprises a dimple extending into a lumen of the needle.
- Embodiments of the invention may include one or more of the following advantages.
- the length of a flexible member spanning across a tear in tissue can be shortened to close the tear by tensioning the flexible member with no additional manipulation being required to limit loosening of the flexible member.
- First and second fixation members can be deployed using a single hollow needle, rather than two separate needles. After deploying a fixation member, the surgeon need not tie an additional knot.
- the length of a flexible member coupled to the fixation member can be adjusted after deploying the fixation member, allowing a surgeon to set the tension in the flexible member to a desired level.
- the device uses a flexible member, such as a suture, to close the tissue wound, rather than inflexible staples or tacks, the tissue is not significantly damaged when it expands and contracts.
- a flexible member such as a suture
- the fixation members do not damage the meniscal tissue when the knee moves.
- a closure device 8 for mending a tear 12 in soft tissue 14, e.g., meniscus of the knee joint includes a flexible member, e.g., suture 10, coupled to a first fixation member 16 and a second fixation member 18.
- Suture 10 is fastened to fixation member 16 to limit movement of suture 10 relative to fixation member 16, while suture 10 is movable relative to fixation member 18.
- fixation members 16 and 18 lie on a surface 20 of tissue 14, for example, the outer surface of the meniscus.
- Suture 10 has a first suture length 10a extending from first fixation member 16 through tissue 14, traversing tear 12, and emerging at a surface 26 of tissue 14; a second suture length 10b extending across surface 26; a third suture length 10c extending back through tissue 14, traversing tear 12 at a location spaced from first length 10a, and emerging at tissue surface 20 where suture 10 loops through second fixation member 18; and a fourth suture length 10d extending from second fixation member 18 through tissue 14, traversing tear 12, and emerging at surface 26.
- Suture 10 has a free end 30 which the surgeon pulls, in the direction of arrow 32, to bring sides 22, 24 of tear 12 together into juxtaposition (as shown in FIG. 10 ).
- suture portion 10c and suture portion 10d are tied together prior to implantation of device 8 to form a retaining element in the form of a slip knot 28 that allows suture 10 to be pulled in the direction of arrow 32, but does not allow tension on suture 10 to pull suture 10 in the opposite direction, which would allow tear 12 to re-open.
- fixation member 16 defines holes 16a, 16b for receiving suture
- fixation member 18 defines holes 18a, 18b for receiving suture 10.
- suture 10 is attached to fixation member 16 by threading suture 10 through a needle 50, and passing needle 50 and suture 10 through holes 16a, 16b in fixation member 16 ( FIG. 2A ).
- Suture 10 now defines a long suture section 52 and a short suture section 54.
- Long suture section 52 is then attached to short suture section 54 by passing needle 50 and long suture section 52 through short suture section 54 at a region 56 ( FIG. 2B ).
- Pulling long suture section 52 away from fixation member 16 FIG. 2C
- draws region 56 toward fixation member 16 forming a knot 60 FIG. 2D ).
- Suture 10 is now secured to fixation member 16.
- suture 10 is now attached to fixation member 18 by passing long suture section 52 through holes 18a, 18b in second fixation member 18 ( FIG. 2E ).
- Long suture section 52 now defines a first suture length 62 and second suture length 64.
- Slip knot 28 is formed by passing fixation member 16 under suture length 64, over suture length 64, and under suture length 62, forming a loop 66 ( FIG. 2F ); then passing fixation member 16 over suture lengths 62 and 64, forming a loop 68 ( FIG. 2G ); and then passing fixation member 16 under suture lengths 64 and 62 ( FIG. 2G ), and finally through loop 68 ( FIG. 2H ).
- a delivery device 99 for implanting device 8 in tissue 14 includes a sheath 200 and a needle 100.
- Sheath 200 is preferably formed from plastic, and needle 100 is preferably metal.
- Needle 100 has an open distal end 111 with a pointed, tissue piercing tip 108.
- Needle 100 has an inner surface 102 defining a lumen 104 and a slot 110 both extending to open distal end 111.
- Slot 110 extends from an outer surface 106 of needle 100 to lumen 102.
- needle 100 receives fixation member 16 and 18 within lumen 104 and slot 110 with suture 10 tied to fixation members 16, 18 as illustrated in FIGS. 2A-2I .
- Sheath 200 defines a lumen 202 which receives needle 100 and device 8 with suture 10 positioned between needle 100 and sheath 200 and extending through a hole 201 defined at a proximal end 203 of sheath 200. Sheath 200 has a distal end 202 from which needle 100 extends.
- slot 110 has a proximal, closed end 120 and a distal open end 140.
- Fixation members 16 and 18 (which are generally described in U.S. Serial No. 09/453,120 , supra) have the same shape with each fixation member including a cylindrical region 151 received within lumen 104 of needle 100, and a fin 152 extending through slot 110 with a portion 154 of fin 152 extending beyond outer surface 106 of needle 100.
- Fixation member 16 is located at a distal region 112 of slot 110, and fixation member 18 is located at a proximal region 114 of slot 110.
- Distal end 111 of needle 100 is indented, for example, crimped at 150, and inner surface 102 of needle 100 has a protrusion extending into lumen 104, for example, a dimple 130, near distal end 140.
- Dimple 130 and crimp 150 are sized to resist unintentional passage of the fixation members either over dimple 130 or through open distal end 111, though only a small force on the fixation members is needed to overcome the resisting load applied to the fixation members by crimp 150 and dimple 130.
- Fixation members 16, 18 have sloped surfaces 152a which aid in passage through tissue, and a flat surface 154a which aid in retention of the fixation member at their deployment sites.
- a needle 100a includes a ramp 130a formed by making three slits in a wall 101 1 of needle 100a and bending a section of the wall toward the inside of the needle.
- needle 100 has a proximal end 160 mounted to a handle 180.
- a push rod 170 FIG. 4
- Handle 180 includes an actuating slider 190 attached to push rod 170 for advancing push rod 170.
- an outer protective tube 200a can be placed over sheath 200.
- Tube 200a protects the needle tip during shipping. If it is desired to supply the surgeon with a variable length depth stop, tube 200a can be provided with gradations 201. The surgeon scores tube 200a to provide the tube with the desired length for the surgical procedure.
- Tube 200a is coupled to handle 190 by a loose interference fit to allow the surgeon to remove tube 200a if tube 200a is not being used during surgery.
- a removable cannula 202a formed, for example, of a plastic material, can be placed over sheath 200.
- Cannula 202a has a distal, tissue penetrating tip 203a and a slot 204a extending from a proximal end 205a of cannula 202a to within about 0.02 inches (0.05cm) of distal tip 203a to define a distal region 206a.
- Slot 204a permits the removal of cannula 202a from delivery device 99 after placement of the delivery device in the joint.
- cannula 202a To remove cannula 202a, the surgeon grasps the cannula and moves it laterally relative to sheath 200, until sheath 200 slides through slot 204a. The surgeon then pulls cannula 202a proximally, which breaks cannula region 206a, permitting complete removal of cannula 202a.
- the user inserts delivery device 99 into, for example, the knee joint, and passes needle 100 through soft tissue 14 and across tear 12, until needle tip 108 and fixation member 16 extend through tissue surface 20.
- Dimple 130 prevents fixation member 16 from sliding proximally in response to forces acting on fixation member 16 during insertion through tissue 14.
- Fixation member 16 is now positioned with flat, tissue facing surface 154a of portion 154 of fin 152 extending beyond needle surface 106 engaging tissue surface 20 ( FIG. 7 ).
- the user then pulls delivery device 99 proximally removing needle 100 from tissue 14 ( FIG. 8 ).
- fixation member 16 The force of the engagement of fixation member 16 with tissue surface 20 during removal of needle 100 overcomes the retention force of crimp 150. Fixation member 16 slides distally out of open end 111 of needle 100 and remains at surface 20. During the retraction of needle 100, a portion of suture 110 with knot 28 is played out of delivery device 99, with suture 10 extending through soft tissue 14 across tear 12.
- the force of the engagement of fixation member 18 with tissue surface 20 during removal of needle 100 overcomes the retention force of crimp 150 such that fixation member 18 slides distally out of open end 111 of needle 100 and remains at surface 20, as described above with reference to fixation member 16.
- Free end 30 of suture 10 extends from sheath 200, as shown in FIG. 11 .
- the user grasps free end 30 of suture 10 with forceps or by hand and pulls on free end 30 of suture 10. This shortens the length of suture between fixation members 16 and 18 (suture portions 10a-10c) bringing sides 22, 24 of tear 12 into juxtaposition, as shown in FIG. 11 .
- slip knot 28 moves closer to fixation member 18.
- slip knot 28 will either be on tissue surface 26 or move within tissue 14.
- Slip knot 28 allows suture 10 to slide in the direction of arrow 32, but does not allow suture 10 to slide in the opposite direction.
- a separate retaining element 210 is positioned on free end 30 of suture 10. While pulling on free end 30, the surgeon advances retaining element 210 through tissue 14, in the direction of arrow 212, until retaining element 210 is positioned against fixation member 18, as shown in dashed line. This action acts to close tear 12 and secure device 8 in place.
- Retaining element 210 defines a through bore 216 for receiving suture 10.
- the material of retaining element 210 e.g., acetal, is selected, and the diameter of through bore 216 is sized relative to suture 10 to provide the desired amount of friction between suture 10 and retaining element 210 for adequate securement.
- the user can slide suture 10 in the direction of arrow 212, but adequate friction is provided between suture 10 and retaining element 210 to limit sliding of retaining element 210 in the opposite direction under normal loads in the knee joint.
- a retaining element 210a defines two angled channels 218, 220 for receiving free end 30 of suture 10.
- Retaining element 210a has a generally cylindrical surface 221 and ends 222, 223.
- Channel 218 has a first opening 224 at end 222 and second opening 225 on surface 221.
- Channel 220 has a first opening 226 at end 223 and a second opening 227 on the same side of surface 221 as channel 218.
- Suture 10 follows a tortuous path through channel 218, over surface 221 between openings 225 and 227, and then through channel 220 with free end 30 extending from opening 226. The tortuous path aids in securement of device 8.
- a retaining element 210b defines two angled channels 218a, 220a each having a channel end 225a, 227a, respectively, on opposite sides of surface 221. Suture 10 thus wraps part way around element 210b to aid in securement of device 8.
- retaining element 210, 210a, or 210b is positioned along suture 10 between the portions of suture 10 passing through fixation member 18.
- Retaining elements 210, 210a, 210b are slidably received on suture 10.
- the retaining element slides over suture 10, changing position relative to fixation member 18, while in the embodiment of FIG. 12C , suture 10 slides within the retaining element with the position of the retaining element being relatively unchanged relative to fixation member 18.
- knot 230 is first tied in free end 30 of suture 10 and pushed, in the direction of arrow 240, through tissue 14 and against fixation member 18, as shown in dashed line.
- knot 230 includes three crossing points, labeled, 230a, 230b, and 230c.
- T When under tension, T, knot 230 tends to tighten upon itself, rather than slide in the direction of arrow 240 making it difficult to advance knot 230 along suture 10.
- a knot pusher 250 is used to enable tension, T, to be applied to suture 10 at the same time knot 230 is advanced in the direction of arrow 240.
- Knot pusher 250 is configured to keep suture at crossing points 230a, 230b, and 230c from touching, such that knot 230 does not tighten upon itself under tension, T. This permits knot 230 to slide along the tensioned suture when knot pusher 250 is advanced in the direction of arrow 240.
- Knot pusher 250 has a cylindrical body 252 and an end post 253.
- Body 252 defines a first groove 254 and a second groove 256 on one surface, and a third groove 258 that is an extension of groove 256 on an opposite surface.
- Grooves 254 and 256 form and X pattern, and grooves 256 and 258 define a loop 260 extending around body 252.
- the three grooves differ in depth, with groove 256 being the shallowest and groove 258 being the deepest.
- knot pusher 250 is removed by pulling retrograde on the knot pusher.
- a tube (not shown) can be advanced over knot pusher 250 between the knot pusher and the suture. As the tube is advanced past suture crossing point 230a, the suture is stripped from knot pusher 250.
- fixation members 16 and 18 are implanted as described above, with suture 10 being tightened to secure fixation members 16 and 18 in place. Additional fixation member 18a is then implanted and suture 10 tightened to secure fixation member 18a in place.
- slot 110 in needle 100 of delivery device 99 is extended.
- additional fixation members 18a preferably include a through bore (not shown) for passage therethrough by push rod 170.
- Push rod 170 preferably is biased off angle such that when push rod 170 is pulled out of the passage in fixation member 18a, the push rod is no longer aligned with the passage. Subsequent advancement of push rod 170 then engages an end face of fixation member 18a to push the fixation member toward the tip of the needle 100, rather than back through the passage. Slider 190 is preferably spring loaded such that after fixation member 18 is pushed out of needle 100, push rod 170 springs back to engage the next fixation member 18a.
- fixation member 16 and 18 in needle 100 can be swapped, with fixation member 18 located in distal region 112 such that fixation member 18 is implanted in the tissue prior to implantation of fixation member 16.
- fixation member 18 is attached to fixation member 16 the same as the attachment to fixation member 18, such that a second slip knot 28a is formed and a second free end 30a of suture extends from fixation member 16.
- both ends 30 and 30a of suture 10 are pulled.
- a suture 266 is attached to fixation members in the form of a first anchor member 270 and a second anchor member 272.
- Members 270, 272 are, for example, TAG WEDGE bone anchors available from Smith & Nephew, Inc. Endoscopy Division, Andover, MA. Other bone anchors known in the art can be employed.
- Suture 266 has a first end 274 fixed to anchor member 270, a second free end 276, and a slip knot 268, formed as described above for slip knot 28.
- Suture 266 preferably passes through a separate suture loop 278, rather than through 272 itself.
- Suture loop 278 acts as a good pulley allowing suture 266 to slide relative to suture loop 278.
- the user forms bone holes 280, 282 in bone 264.
- the user implants anchor member 270 in bone hole 280, with suture 266 already threaded as shown, followed by implanting anchor member 272 in bone hole 282.
- the user then pulls on free end 276 of suture 266, which brings soft tissue 262 against bone 264.
- Slip knot 268 limits loosening of suture 266.
- suture loop 2708 suture 266 is not located within bone hole 282 in use thus limiting the possibility of trapping suture 266 against wall 284 of bone hole 282. If suture 266 were trapped in bone hole 282, pulling free end 276 of suture 266 would not result in shortening the length of suture between anchors 270, 272, which acts to secure soft tissue 262 against bone 264.
- a device 308 not falling under the scope of the invention for repairing a tear 12 in tissue 14 includes a suture 310 attached to a single fixation member 326.
- Fixation member 326 defines through holes 330, 332 for receiving suture 310.
- Suture 310 has a first end 312 attached to suture 310 at point 314 (as described above with reference to FIG. 2B ) to form a looped end 316 remote from fixation member 326, and a second, free end 334.
- fixation member 326 When implanted in the knee joint, fixation member 326 lies on a surface 20 of tissue 14. Looped end 316 is located in tear 12 and extends along surface 26 of tissue 14. Suture 310 extends through tissue 14, passing through looped end 316 in tear 12, and emerging at tissue surface 20 where suture 310 loops through fixation member 326. Suture 310 extends back through tissue 14, passing through looped end 316 in tear 12 and through a slip knot 321 formed in suture 310, and emerging at tissue surface 26. As described further below, after device 308 is positioned in tissue 14, the user pulls on free end 334 of suture 310, in the direction of arrow 520, to bring sides 22, 24 of tear 12 together into juxtaposition (as shown in FIG. 16 ). Slip knot 321 limits loosening of suture 310. Alternatively, looped end 316 is located on surface 20 between fixation member 326 and surface 20, as shown in dashed line in FIG. 16 .
- a delivery device 399 for implanting device 308 not falling under the scope of the invention includes a suture holder 400 and needle 460.
- Suture holder 400 includes a tube 410 defining a lumen 415 through which needle 460 extends, a shaft 420, and a distal portion 430.
- Distal portion 430 has a first tine 440 defining grooves 445 and 446, and a second tine 450 defining grooves 455, 456.
- Needle 460 has a beveled tip 461 and a slot 462 in a top portion 463 of needle 460.
- fastening member 326 with attached suture 310 is positioned in slot 462 with suture 310 preformed with looped end 316 and slip knot 321.
- Slip knot 321 is formed as described above with reference to FIGS. 2A-2I , though where fixation member 16 is positioned in FIGS. 2A-2I , suture 310 is formed as looped end 316 ( FIG. 19C ). Looped end 316 is positioned on suture holder 400 within grooves 445, 446, 455 and 456 of tines 440, 450 ( FIG. 19B ), and extends along a bottom side 480 of shaft 420.
- delivery device 399 includes a handle 451 with a push knob 453 for advancing needle 460 relative to suture holder 400.
- the user inserts distal portion 430 of suture holder 400 into tear 12 of tissue 14, and then advances needle 460 through tissue 14, traversing tear 12, and exiting tissue 14 at tissue surface 20. Needle 460 passes between tines 440 and 450, and thus through looped end 316 of suture 310 ( FIG. 21 ). The user then retracts needle 460 from tissue 14 ( FIG. 22 ). The contact of fastening member 326 with tissue surface 20 during the retraction of needle 460 acts to push fastening member 326 out of needle 460 such that fastening member 326 remains at surface 20, as described above with reference to FIG. 7 . Pulling on free end 334 of suture 310 brings sides 22, 24 of tear 12 into juxtaposition. Slip knot 321 secures device 308 in place. Excess suture 310 can then be cut off.
- suture 310 includes a retaining element in the form of a Chinese trap or hand cuff 495, that is, an element that when pulled on, tightens around something disposed within the element. Free end 334 of suture 310 is slidably received within trap 495. When free end 334 of suture 310 is pulled in the direction of arrow 520 trap 495 is stretched, eventually gripping suture passing therethrough to secure suture 310 and device 308.
- the retaining element can also take the form of retaining elements described above with reference to FIGS. 12-12C and 13 .
- a device 799 not falling under the scope of the invention for repairing tear 12 in tissue 14 includes a barbed fastening member 800 and a suture 820.
- Suture 820 has an end 810 attached to fastening member 800.
- Suture 820 is formed in loop 830 with a second end 832 of suture 820 attached to suture 820.
- Delivery device 399 can be used to deploy device 799 with suture 820 being tightened to close tear 12 by pushing fastening member 800 in the direction of arrow 840, rather than pulling on a free end of suture.
- Barbed fastening member 800 limits loosening of suture 820.
- an alternative embodiment of a fixation member 600 which can be used in any of the above embodiments, includes through bores 610, 620 with radiused corners 615 to reduce friction between suture 470 and fixation member 600.
- another embodiment of a fixation member 650 which can be used in any of the above embodiments, includes a solid rod 660 with ends 680, 690, and a braided suture 670 attached to ends 680, 690.
- Suture 670 forms a loop 700 for receiving suture 10 or suture 310. Loop 700 lines up with suture 10, 310 to act as a pulley and reducing friction between the suture and fixation member.
- fixation members, securement elements, and suture of the above embodiments can be formed of a biodegradable material.
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Abstract
Description
- The invention relates to a closure device for tissue repair.
- Fibrous tissue wounds, such as muscle, ligament, and cartilage tears, can be repaired arthroscopically using sutures. Traditionally, to close a fibrous tissue wound, a surgeon would insert two suture needles into the tissue with sutures attached, thread the sutures across the wound, and then tie knots to fix the free ends of the sutures within the tissue.
- To simplify the wound closure procedure and to improve fixation, various types of suture anchors have been developed. One example of a suture anchor is disclosed in Hayhurst,
U.S. Patent No. 4,741,330 . In Hayhurst, one end of a suture is fixed to a resiliently-deformable, bar-shaped suture anchor. The anchor is loaded into the bore of a hollow needle and deployed into or against the fibrous tissue. The surgeon then threads the suture across the wound and tensions a free end of the suture to pull the wound closed. When the surgeon tensions the suture, the bar in the anchor becomes oriented transversely to the suture hole, anchoring the suture in place. - Again,
U.S. Patent No. 4,235,238 describes an apparatus for suturing coeliac tissues and has been used for the delineation in two-part form of claim 1. - A surgical method, enabled by the present invention, includes positioning a fixation member relative to tissue, moving a flexible member coupled to the fixation member relative to the fixation member to bring two tissue surfaces together, and moving a retaining element coupled to the flexible member relative to the fixation member. The retaining element acts to limit loosening of the flexible member relative to the fixation member.
- The method enabled by the present invention, may include one or more of the following features.
- The step of moving the flexible member comprises pulling the flexible member. The step of moving the flexible member also accomplishes the step of moving the retaining element, which is, for example, a slip knot. Alternatively, the step of moving the retaining element includes moving the retaining element relative to the flexible element. The retaining element is, for example, a friction element which permits sliding of the retaining element relative to the flexible element in only one direction. In another illustrated embodiment the retaining element is in the form of an overhand knot, and the method includes advancing the overhand knot along the flexible element. In another illustrated embodiment, the retaining element is in the form of a Chinese trap.
- In an exemplary embodiment, the step of moving the flexible member includes pulling on only one end of the flexible member.
- In another illustrated embodiment, the method includes positioning a second fixation member relative to the tissue. The second fixation member is coupled to the flexible member, either movably or fixedly. The step of moving the flexible member includes, for example, pulling on two ends of the flexible member or pulling on only one end of the flexible member.
- The step of positioning the fixation member includes positioning the fixation member on an outer surface of the tissue, and the two tissue surfaces brought together are both soft tissue. Alternatively, the fixation member is positioned in a bone hole, and one of the two tissue surfaces brought together is bone and the other soft tissue.
- In another illustrated embodiment, the step of positioning the fixation member includes passing the fixation member through a loop of the flexible member. The loop is positioned within a tear in soft tissue.
- The invention enables a method for repairing a tear in soft tissue includes advancing a fixation member coupled to a flexible member through tissue on either side of the tear and through a loop of the flexible member, and tensioning the flexible member to bring two tissue surfaces on either side of the tear together.
- Embodiments of this method may include one or more of the following features. The loop is positioned within the tear. The method includes pulling an end of the flexible member to bring the two tissue surfaces together. The fixation member is in the form of a barbed member.
- According to one aspect of the invention, there is provided an apparatus for repairing a tear in soft tissue comprising:
- at least two fixation members located on the surface of the tissue, a flexible member substantially immovable secured to a first of the fixation members and movably coupled to a second of the fixation members, and
- a retaining element coupled to the flexible member, the retaining element being movable relative to the second fixation member and acting to limit loosening of the flexible member relative to the second fixation member by allowing pulling of said flexible member in one direction only; characterised in that the retaining element is coupled to a portion of the flexible member that extends between the first and second fixation members.
- Preferably, tightening of the flexible member secures the fixation members.
- Preferably, the retaining element coupled to the flexible member is slidably received by the flexible member.
- Preferably, the flexible member is movably coupled to the second fixation member such that a first end of the flexible member is looped back and secured to the second flexible member to form a loop, the loop being remote from the fixation member.
- Preferably, the apparatus further comprises:
- a shaft
- a first tine at an end region of the shaft defining a first region for receiving a first portion of a loop of a flexible member; and
- a second tine at the end region of the shaft defining a second region for receiving a second portion of the loop of the flexible member.
- Preferably, the shaft comprises a tube.
- Preferably, the first and second regions comprises a groove.
- Preferably, the apparatus further comprises:
- a needle having a distal region and a proximal region, the distal region being defined between two holding elements.
- Preferably, the first fixation member is positioned within the distal region before fixation on tissue and the second fixation member is positioned within the proximal region before fixation on tissue.
- Preferably, one of the holding elements comprises a crimp in the needle in the distal region.
- Preferably, one of the holding elements comprises a dimple extending into a lumen of the needle.
- Embodiments of the invention may include one or more of the following advantages. The length of a flexible member spanning across a tear in tissue can be shortened to close the tear by tensioning the flexible member with no additional manipulation being required to limit loosening of the flexible member. First and second fixation members can be deployed using a single hollow needle, rather than two separate needles. After deploying a fixation member, the surgeon need not tie an additional knot. The length of a flexible member coupled to the fixation member can be adjusted after deploying the fixation member, allowing a surgeon to set the tension in the flexible member to a desired level.
- Since the device uses a flexible member, such as a suture, to close the tissue wound, rather than inflexible staples or tacks, the tissue is not significantly damaged when it expands and contracts. For example, if the soft tissue is a meniscus, the fixation members do not damage the meniscal tissue when the knee moves.
- The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent form the description and drawings, and from the claims.
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FIG. 1 is an illustration of a closure device according to the invention, shown mending a tear in soft tissue; -
FIGS. 2A - 21 show a method of tying a slip knot in suture of the closure device ofFIG. 1 ; -
FIG. 3 is a perspective view of a delivery device for inserting the closure device ofFIG. 1 into soft tissue; -
FIG. 4 is a perspective view of the delivery device ofFIG. 3 shown with an outer sheath removed; -
FIG. 4A is a perspective view of a fixation member of the closure device ofFIG. 1 ; -
FIG. 4B is a cross-sectional end view of the delivery device ofFIG. 4 , taken alonglines 4B-4B; -
FIG. 4C is a cross-sectional side view of an alternative embodiment of a needle of the delivery device ofFIG. 3 . -
FIG. 5 is side view of the delivery device ofFIG. 3 ; -
FIG. 5A is a side view of a variable length depth stop for use with the delivery device ofFIG. 3 ; -
FIG. 5B is a perspective view of a cannula for use with the delivery device ofFIG. 3 ; -
FIGS. 6-11 show the delivery device in use inserting the closure device ofFIG. 1 in soft tissue, withFIG. 7 being an exploded view of region 7 ofFIG. 6 ; -
FIG. 12 is an illustration of the closure device ofFIG. 1 with an alternative embodiment of a retaining element, shown mending a tear in soft tissue; -
FIGS. 12A and 12B show alternative embodiments of the retaining element ofFIG. 11 ; -
FIG. 12C shows the retaining element ofFIG. 12 in an alternative position; -
FIG. 13 shows an additional alternative embodiment of a retaining element in the form of an overhand knot; -
FIGS. 13A and 13B show an overhand knot and a knot pusher for advancing the overhand knot ofFIG. 13 ; -
FIG. 14 is an illustration of an alternative embodiment of a closure device; -
FIG. 14A shows an alternative arrangement of the closure device and delivery device ofFIG. 4 ; -
FIG. 14B is an illustration of an alternative embodiment of a closure device; -
FIG. 15 is an illustration of an alternative embodiment of a closure device for use in attaching soft tissue to bone; -
FIG. 16 is a cross-sectional side view of an alternative embodiment of a closure device not falling under the scope of the invention, shown mending a tear in soft tissue; -
FIG. 17 shows the closure device ofFIG. 16 in use prior to securing the closure device in place; -
FIG. 18 is a top view of the closure device ofFIG. 16 , shown after securing the closure device in place; -
FIG. 19 is a side view of a delivery device for inserting the closure device ofFIG. 16 in soft tissue; -
FIG. 19A is a perspective view of a distal section of the delivery device ofFIG. 19 shown with a fixation member of the closure device ofFIG. 16 ; -
FIG. 19B is a perspective view similar to that ofFIG. 19A shown with the closure device ofFIG. 16 ; -
FIG. 19C is an illustration of the closure device ofFIG. 16 ; -
FIGS. 20-22 show the delivery device ofFIG. 19 in use inserting the closure device ofFIG. 16 in soft tissue; -
FIG. 23 is a cross-sectional side view of the closure device of F1G. 16 with an alternative embodiment of a retaining element, shown mending a tear in soft tissue; -
FIG. 24 is a cross-sectional side view of an alternative embodiment of a closure device also not falling under the scope of the invention, similar in use to the closure device ofFIG. 16 ; -
FIGS. 25 and 26 are alternative embodiments of a fixation member of the closure device ofFIG. 16 . - Referring to
FIG. 1 , aclosure device 8 for mending atear 12 insoft tissue 14, e.g., meniscus of the knee joint, includes a flexible member, e.g.,suture 10, coupled to afirst fixation member 16 and asecond fixation member 18.Suture 10 is fastened tofixation member 16 to limit movement ofsuture 10 relative tofixation member 16, whilesuture 10 is movable relative tofixation member 18. - When implanted in the knee joint,
fixation members surface 20 oftissue 14, for example, the outer surface of the meniscus.Suture 10 has afirst suture length 10a extending fromfirst fixation member 16 throughtissue 14, traversingtear 12, and emerging at asurface 26 oftissue 14; asecond suture length 10b extending acrosssurface 26; athird suture length 10c extending back throughtissue 14, traversingtear 12 at a location spaced fromfirst length 10a, and emerging attissue surface 20 wheresuture 10 loops throughsecond fixation member 18; and a fourth suture length 10d extending fromsecond fixation member 18 throughtissue 14, traversingtear 12, and emerging atsurface 26.Suture 10 has afree end 30 which the surgeon pulls, in the direction ofarrow 32, to bringsides tear 12 together into juxtaposition (as shown inFIG. 10 ). - As described further below,
suture portion 10c and suture portion 10d are tied together prior to implantation ofdevice 8 to form a retaining element in the form of aslip knot 28 that allowssuture 10 to be pulled in the direction ofarrow 32, but does not allow tension onsuture 10 to pullsuture 10 in the opposite direction, which would allowtear 12 to re-open. - Referring to
FIGS. 2A - 21 , prior to insertion intotissue 14,suture 10 is attached tofixation members slip knot 28 is formed.Fixation member 16 definesholes suture 10, andfixation member 18 definesholes 18a, 18b for receivingsuture 10. As illustrated inFIGS. 2A-2D ,suture 10 is attached tofixation member 16 by threadingsuture 10 through aneedle 50, and passingneedle 50 andsuture 10 throughholes FIG. 2A ).Suture 10 now defines along suture section 52 and ashort suture section 54.Long suture section 52 is then attached toshort suture section 54 by passingneedle 50 andlong suture section 52 throughshort suture section 54 at a region 56 (FIG. 2B ). Pullinglong suture section 52 away from fixation member 16 (FIG. 2C ) then drawsregion 56 towardfixation member 16 forming a knot 60 (FIG. 2D ).Suture 10 is now secured tofixation member 16. - Referring to
FIGS. 2E-2I ,suture 10 is now attached tofixation member 18 by passinglong suture section 52 throughholes 18a, 18b in second fixation member 18 (FIG. 2E ).Long suture section 52 now defines afirst suture length 62 andsecond suture length 64.Slip knot 28 is formed by passingfixation member 16 undersuture length 64, oversuture length 64, and undersuture length 62, forming a loop 66 (FIG. 2F ); then passingfixation member 16 oversuture lengths FIG. 2G ); and then passingfixation member 16 undersuture lengths 64 and 62 (FIG. 2G ), and finally through loop 68 (FIG. 2H ). Pullingfixation member 16 relative tofixation member 18 tightens slip knot 28 (FIG. 21 ). Pullingfree end 30 ofsuture 10 now acts to slidesuture 10 throughslip knot 28, whileslip knot 28 limits sliding ofsuture 10 in the opposite direction whensuture 10 is under tension. - Referring to
FIG. 3 , adelivery device 99 for implantingdevice 8 intissue 14 includes asheath 200 and aneedle 100.Sheath 200 is preferably formed from plastic, andneedle 100 is preferably metal.Needle 100 has an opendistal end 111 with a pointed,tissue piercing tip 108.Needle 100 has aninner surface 102 defining alumen 104 and aslot 110 both extending to opendistal end 111.Slot 110 extends from anouter surface 106 ofneedle 100 tolumen 102. As described further below,needle 100 receivesfixation member lumen 104 and slot 110 withsuture 10 tied tofixation members FIGS. 2A-2I .Sheath 200 defines alumen 202 which receivesneedle 100 anddevice 8 withsuture 10 positioned betweenneedle 100 andsheath 200 and extending through ahole 201 defined at aproximal end 203 ofsheath 200.Sheath 200 has adistal end 202 from which needle 100 extends. - Referring also to
FIGS. 4-4B ,slot 110 has a proximal,closed end 120 and a distalopen end 140.Fixation members 16 and 18 (which are generally described inU.S. Serial No. 09/453,120 cylindrical region 151 received withinlumen 104 ofneedle 100, and afin 152 extending throughslot 110 with aportion 154 offin 152 extending beyondouter surface 106 ofneedle 100.Fixation member 16 is located at adistal region 112 ofslot 110, andfixation member 18 is located at aproximal region 114 ofslot 110.Distal end 111 ofneedle 100 is indented, for example, crimped at 150, andinner surface 102 ofneedle 100 has a protrusion extending intolumen 104, for example, adimple 130, neardistal end 140.Dimple 130 and crimp 150 are sized to resist unintentional passage of the fixation members either overdimple 130 or through opendistal end 111, though only a small force on the fixation members is needed to overcome the resisting load applied to the fixation members bycrimp 150 anddimple 130.Fixation members surfaces 152a which aid in passage through tissue, and aflat surface 154a which aid in retention of the fixation member at their deployment sites. - During manufacturing, to position
fixation members needle 100, aftersuture 10 is attached tofixation members fixation member 18 is loaded inneedle 100 by passingfixation member 18 throughdistal end 111 and slidingfixation member 18 alonglumen 104 and slot 110 toproximal end 120 ofslot 110.Fixation member 16 is then loaded inneedle 100 by passingfixation member 16 throughdistal end 111 andpositioning fixation member 16 inregion 112.Dimple 130 and crimp 150 are then formed.Fixation member 16 is now restrained from unintentional movement in the proximal direction bydimple 130 and in the distal direction bycrimp 150. Alternatively, as shown inFIG. 4C , rather thandimple 130, aneedle 100a includes aramp 130a formed by making three slits in awall 101 1 ofneedle 100a and bending a section of the wall toward the inside of the needle. - Referring also to
FIG. 5 ,needle 100 has aproximal end 160 mounted to ahandle 180. Located withinneedle 100, proximal offixation member 18, is a push rod 170 (FIG. 4 ) used to advancefixation member 18, as described below. Handle 180 includes anactuating slider 190 attached to pushrod 170 for advancingpush rod 170. Oncedevice 8 is secured toneedle 100, as described above,sheath 200 is placed overneedle 100, with the majority ofsuture 10 located within and protected bysheath 200.Sheath 200 also covers the majority offixation member 18 and helps keepfixation member 18 in position.Sheath 200 is then secured to handle 180 by an interference fit. Thedistance needle 100 extends fromsheath 200 determines the penetration depth ofneedle 100 into the tissue.Delivery device 99 is supplied to the surgeon withdevice 8 pre-loaded inneedle 100. - Referring to
FIG. 5A , an outerprotective tube 200a can be placed oversheath 200.Tube 200a protects the needle tip during shipping. If it is desired to supply the surgeon with a variable length depth stop,tube 200a can be provided withgradations 201. The surgeon scorestube 200a to provide the tube with the desired length for the surgical procedure.Tube 200a is coupled to handle 190 by a loose interference fit to allow the surgeon to removetube 200a iftube 200a is not being used during surgery. - Referring to
FIG. 5B , to eliminate the need for placement ofdelivery device 99 through an arthroscopy cannula, aremovable cannula 202a, formed, for example, of a plastic material, can be placed oversheath 200.Cannula 202a has a distal,tissue penetrating tip 203a and aslot 204a extending from aproximal end 205a of cannula 202a to within about 0.02 inches (0.05cm) ofdistal tip 203a to define adistal region 206a.Slot 204a permits the removal of cannula 202a fromdelivery device 99 after placement of the delivery device in the joint. To remove cannula 202a, the surgeon grasps the cannula and moves it laterally relative tosheath 200, untilsheath 200 slides throughslot 204a. The surgeon then pulls cannula 202a proximally, which breakscannula region 206a, permitting complete removal of cannula 202a. - Referring to
FIGS. 6-11 , in use, preferably under arthroscopic guidance, the user insertsdelivery device 99 into, for example, the knee joint, and passesneedle 100 throughsoft tissue 14 and acrosstear 12, untilneedle tip 108 andfixation member 16 extend throughtissue surface 20.Dimple 130 preventsfixation member 16 from sliding proximally in response to forces acting onfixation member 16 during insertion throughtissue 14.Fixation member 16 is now positioned with flat,tissue facing surface 154a ofportion 154 offin 152 extending beyondneedle surface 106 engaging tissue surface 20 (FIG. 7 ). The user then pullsdelivery device 99 proximally removingneedle 100 from tissue 14 (FIG. 8 ). The force of the engagement offixation member 16 withtissue surface 20 during removal ofneedle 100 overcomes the retention force ofcrimp 150.Fixation member 16 slides distally out ofopen end 111 ofneedle 100 and remains atsurface 20. During the retraction ofneedle 100, a portion ofsuture 110 withknot 28 is played out ofdelivery device 99, withsuture 10 extending throughsoft tissue 14 acrosstear 12. - The user then advances
slider 190, advancingrod 170 to pushfixation member 18 distally, overdimple 130, to reside inregion 112 betweendimple 130 and crimp 150 (FIG. 9 ). The user then movesneedle 100 to a spaced location to the side ofexit point 229 ofsuture 10 fromtissue 14, andre-inserts needle 100 intosoft tissue 14, acrosstear 12, and throughsurface 20, untilneedle tip 108 andfixation member 18 extend through tissue surface 20 (FIG. 10 ). The user then pullsdelivery device 99 proximally removingneedle 100 from tissue 14 (FIG. 11 ). The force of the engagement offixation member 18 withtissue surface 20 during removal ofneedle 100 overcomes the retention force ofcrimp 150 such thatfixation member 18 slides distally out ofopen end 111 ofneedle 100 and remains atsurface 20, as described above with reference tofixation member 16. -
Free end 30 ofsuture 10 extends fromsheath 200, as shown inFIG. 11 . The user graspsfree end 30 ofsuture 10 with forceps or by hand and pulls onfree end 30 ofsuture 10. This shortens the length of suture betweenfixation members 16 and 18 (suture portions 10a-10c) bringingsides tear 12 into juxtaposition, as shown inFIG. 11 . Whenfree end 30 ofsuture 10 is pulled,slip knot 28 moves closer tofixation member 18. Depending on the length of suture betweenfixation members slip knot 28 will either be ontissue surface 26 or move withintissue 14.Slip knot 28 allowssuture 10 to slide in the direction ofarrow 32, but does not allowsuture 10 to slide in the opposite direction. The tension placed onsuture 10 by pulling on the suture relative tofixation members long sides 255 are in contact withtissue surface 20.Excess suture 10 can then be cut off. Further manipulation ofsuture 10 is not needed to securefixation members - Referring to
FIG. 12 , rather than aslip knot 28 acting as a retainingelement allowing suture 10 to be tightened while resisting loosening ofsuture 10, here, aseparate retaining element 210 is positioned onfree end 30 ofsuture 10. While pulling onfree end 30, the surgeon advances retainingelement 210 throughtissue 14, in the direction ofarrow 212, until retainingelement 210 is positioned againstfixation member 18, as shown in dashed line. This action acts to closetear 12 andsecure device 8 in place. - Retaining
element 210 defines a throughbore 216 for receivingsuture 10. The material of retainingelement 210, e.g., acetal, is selected, and the diameter of throughbore 216 is sized relative to suture 10 to provide the desired amount of friction betweensuture 10 and retainingelement 210 for adequate securement. Thus, the user can slidesuture 10 in the direction ofarrow 212, but adequate friction is provided betweensuture 10 and retainingelement 210 to limit sliding of retainingelement 210 in the opposite direction under normal loads in the knee joint. - Referring to
FIG. 12A , a retainingelement 210a defines twoangled channels free end 30 ofsuture 10. Retainingelement 210a has a generally cylindrical surface 221 and ends 222, 223.Channel 218 has afirst opening 224 atend 222 andsecond opening 225 on surface 221.Channel 220 has afirst opening 226 atend 223 and asecond opening 227 on the same side of surface 221 aschannel 218.Suture 10 follows a tortuous path throughchannel 218, over surface 221 betweenopenings channel 220 withfree end 30 extending from opening 226. The tortuous path aids in securement ofdevice 8. - In
FIG. 12B , rather the channel opening on surface 221 being on the same side, a retainingelement 210b defines two angled channels 218a, 220a each having achannel end Suture 10 thus wraps part way aroundelement 210b to aid in securement ofdevice 8. - Referring to
FIG. 12C , rather than positioning the retaining element onsuture 10 aftersuture 10 exits fromfixation member 18, here retainingelement suture 10 between the portions ofsuture 10 passing throughfixation member 18. - Retaining
elements suture 10. In the embodiments ofFIGS. 12-12B , the retaining element slides oversuture 10, changing position relative tofixation member 18, while in the embodiment ofFIG. 12C ,suture 10 slides within the retaining element with the position of the retaining element being relatively unchanged relative tofixation member 18. - Referring to
FIG. 13 ,device 8 can be secured totissue 14 using a simpleoverhand knot 230.Knot 230 is first tied infree end 30 ofsuture 10 and pushed, in the direction ofarrow 240, throughtissue 14 and againstfixation member 18, as shown in dashed line. Referring toFIGS. 13A and 13B ,knot 230 includes three crossing points, labeled, 230a, 230b, and 230c. When under tension, T,knot 230 tends to tighten upon itself, rather than slide in the direction ofarrow 240 making it difficult to advanceknot 230 alongsuture 10. To enable tension, T, to be applied to suture 10 at thesame time knot 230 is advanced in the direction ofarrow 240, aknot pusher 250 is used.Knot pusher 250 is configured to keep suture at crossingpoints knot 230 does not tighten upon itself under tension, T. This permitsknot 230 to slide along the tensioned suture whenknot pusher 250 is advanced in the direction ofarrow 240. -
Knot pusher 250 has acylindrical body 252 and an end post 253.Body 252 defines afirst groove 254 and asecond groove 256 on one surface, and athird groove 258 that is an extension ofgroove 256 on an opposite surface.Grooves grooves loop 260 extending aroundbody 252. The three grooves differ in depth, withgroove 256 being the shallowest and groove 258 being the deepest. Thus, whensuture 10 is formed into an overhand knot and positioned withingrooves points knot 230 is advanced againstfixation member 18,knot pusher 250 is removed by pulling retrograde on the knot pusher. To aid in removal ofknot pusher 250, a tube (not shown) can be advanced overknot pusher 250 between the knot pusher and the suture. As the tube is advanced pastsuture crossing point 230a, the suture is stripped fromknot pusher 250. - Referring to
FIG. 14 , one or moreadditional fixation members 18a with aslip knot 28 formed insuture 10 can be added todevice 8. In use,fixation members suture 10 being tightened to securefixation members Additional fixation member 18a is then implanted andsuture 10 tightened to securefixation member 18a in place. To accommodate additional fixation members,slot 110 inneedle 100 ofdelivery device 99 is extended. To permit access tofixation member 18 bypush rod 170,additional fixation members 18a preferably include a through bore (not shown) for passage therethrough bypush rod 170. Pushrod 170 preferably is biased off angle such that whenpush rod 170 is pulled out of the passage infixation member 18a, the push rod is no longer aligned with the passage. Subsequent advancement ofpush rod 170 then engages an end face offixation member 18a to push the fixation member toward the tip of theneedle 100, rather than back through the passage.Slider 190 is preferably spring loaded such that afterfixation member 18 is pushed out ofneedle 100,push rod 170 springs back to engage thenext fixation member 18a. - Referring to
FIG. 14A , the positions offixation member needle 100 can be swapped, withfixation member 18 located indistal region 112 such thatfixation member 18 is implanted in the tissue prior to implantation offixation member 16. Referring toFIG. 14B , rather than suture 10 being fixed tofixation member 16, here suture 10 is attached tofixation member 16 the same as the attachment tofixation member 18, such that asecond slip knot 28a is formed and a secondfree end 30a of suture extends fromfixation member 16. To securefixation members suture 10 are pulled. - Referring to
FIG. 15 , in an application for securingsoft tissue 262 tobone 264, asuture 266 is attached to fixation members in the form of afirst anchor member 270 and asecond anchor member 272.Members Suture 266 has afirst end 274 fixed to anchormember 270, a secondfree end 276, and aslip knot 268, formed as described above forslip knot 28. Suture 266 preferably passes through aseparate suture loop 278, rather than through 272 itself.Suture loop 278 acts as a goodpulley allowing suture 266 to slide relative tosuture loop 278. - In use, the user forms
bone holes bone 264. The user then implants anchormember 270 inbone hole 280, withsuture 266 already threaded as shown, followed by implantinganchor member 272 inbone hole 282. The user then pulls onfree end 276 ofsuture 266, which bringssoft tissue 262 againstbone 264.Slip knot 268 limits loosening ofsuture 266. By usingsuture loop 278,suture 266 is not located withinbone hole 282 in use thus limiting the possibility of trappingsuture 266 againstwall 284 ofbone hole 282. Ifsuture 266 were trapped inbone hole 282, pullingfree end 276 ofsuture 266 would not result in shortening the length of suture betweenanchors soft tissue 262 againstbone 264. - Referring to
FIGS. 16-18 , adevice 308 not falling under the scope of the invention for repairing atear 12 intissue 14 includes asuture 310 attached to asingle fixation member 326.Fixation member 326 defines throughholes suture 310.Suture 310 has afirst end 312 attached to suture 310 at point 314 (as described above with reference toFIG. 2B ) to form a loopedend 316 remote fromfixation member 326, and a second,free end 334. - When implanted in the knee joint,
fixation member 326 lies on asurface 20 oftissue 14. Loopedend 316 is located intear 12 and extends alongsurface 26 oftissue 14.Suture 310 extends throughtissue 14, passing through loopedend 316 intear 12, and emerging attissue surface 20 wheresuture 310 loops throughfixation member 326.Suture 310 extends back throughtissue 14, passing through loopedend 316 intear 12 and through aslip knot 321 formed insuture 310, and emerging attissue surface 26. As described further below, afterdevice 308 is positioned intissue 14, the user pulls onfree end 334 ofsuture 310, in the direction ofarrow 520, to bringsides tear 12 together into juxtaposition (as shown inFIG. 16 ).Slip knot 321 limits loosening ofsuture 310. Alternatively, loopedend 316 is located onsurface 20 betweenfixation member 326 andsurface 20, as shown in dashed line inFIG. 16 . - Referring to
FIGS. 19-19B , adelivery device 399 for implantingdevice 308 not falling under the scope of the invention includes asuture holder 400 andneedle 460.Suture holder 400 includes atube 410 defining alumen 415 through which needle 460 extends, ashaft 420, and adistal portion 430.Distal portion 430 has afirst tine 440defining grooves second tine 450defining grooves Needle 460 has abeveled tip 461 and aslot 462 in atop portion 463 ofneedle 460. - When assembled,
fastening member 326 with attachedsuture 310 is positioned inslot 462 withsuture 310 preformed with loopedend 316 andslip knot 321.Slip knot 321 is formed as described above with reference toFIGS. 2A-2I , though wherefixation member 16 is positioned inFIGS. 2A-2I ,suture 310 is formed as looped end 316 (FIG. 19C ). Loopedend 316 is positioned onsuture holder 400 withingrooves tines 440, 450 (FIG. 19B ), and extends along abottom side 480 ofshaft 420. As shown inFIG. 19 ,delivery device 399 includes ahandle 451 with apush knob 453 for advancingneedle 460 relative to sutureholder 400. - Referring to
FIG. 20 , in use, the user insertsdistal portion 430 ofsuture holder 400 intotear 12 oftissue 14, and then advancesneedle 460 throughtissue 14, traversingtear 12, and exitingtissue 14 attissue surface 20.Needle 460 passes betweentines end 316 of suture 310 (FIG. 21 ). The user then retractsneedle 460 from tissue 14 (FIG. 22 ). The contact offastening member 326 withtissue surface 20 during the retraction ofneedle 460 acts to pushfastening member 326 out ofneedle 460 such thatfastening member 326 remains atsurface 20, as described above with reference toFIG. 7 . Pulling onfree end 334 ofsuture 310 bringssides tear 12 into juxtaposition.Slip knot 321 securesdevice 308 in place.Excess suture 310 can then be cut off. - Referring to
FIG. 23 , rather than securingdevice 308 not falling under the scope of the invention with a slip knot,suture 310 includes a retaining element in the form of a Chinese trap orhand cuff 495, that is, an element that when pulled on, tightens around something disposed within the element.Free end 334 ofsuture 310 is slidably received withintrap 495. Whenfree end 334 ofsuture 310 is pulled in the direction ofarrow 520trap 495 is stretched, eventually gripping suture passing therethrough to securesuture 310 anddevice 308. The retaining element can also take the form of retaining elements described above with reference toFIGS. 12-12C and13 . - Referring to
FIG. 24 , adevice 799 not falling under the scope of the invention for repairingtear 12 intissue 14 includes abarbed fastening member 800 and asuture 820.Suture 820 has anend 810 attached to fasteningmember 800.Suture 820 is formed inloop 830 with asecond end 832 ofsuture 820 attached tosuture 820.Delivery device 399 can be used to deploydevice 799 withsuture 820 being tightened to closetear 12 by pushingfastening member 800 in the direction ofarrow 840, rather than pulling on a free end of suture.Barbed fastening member 800 limits loosening ofsuture 820. - Referring to
FIG. 25 , an alternative embodiment of afixation member 600, which can be used in any of the above embodiments, includes throughbores radiused corners 615 to reduce friction betweensuture 470 andfixation member 600. Referring toFIG. 26 , another embodiment of afixation member 650, which can be used in any of the above embodiments, includes asolid rod 660 withends braided suture 670 attached to ends 680, 690. Suture 670 forms aloop 700 for receivingsuture 10 orsuture 310.Loop 700 lines up withsuture - The fixation members, securement elements, and suture of the above embodiments can be formed of a biodegradable material.
- Other embodiments are within the scope of the following claims.
Claims (11)
- An apparatus for repairing a tear in soft tissue, comprising:at least two fixation members (16,18) located on the surface of the tissue,a flexible member (10) substantially immovable secured to a first of the fixation members (16) and movably coupled to a second of the fixation members (18), anda retaining element (28) coupled to the flexible member (10), the retaining element (28) being movable relative to the second fixation member (18)and acting to limit loosening of the flexible member (10) relative to the second fixation member (18) by allowing pulling of said flexible member in one direction only; characterised in that the retaining element (28) is coupled to a portion (10c) of the flexible member (10) that extends between the first (16) and second (18) fixation members.
- An apparatus as claimed in claim 1 such that tightening the flexible member (10) secures the fixation members (16, 18).
- An apparatus for repair as claimed in any preceding claim in which the retaining element (28) coupled to the flexible member (10) is slidably received by the flexible member (10).
- An apparatus for repair as claimed in any preceding claim in which the flexible member (52) is movably coupled to the second fixation member (18) such that a first end of the flexible member (62) is looped back and secured to the second flexible member (64) to form a loop (66), the loop being remote from the fixation member (18).
- An apparatus as claimed in any preceding claim in which further comprises:a shaft (420)a first tine (440) at an end region of the shaft defining a first region for receiving a first portion of a loop of a flexible member (310); anda second time (450) at the end region of the shaft defining a second region for receiving a second portion of the loop of the flexible member.
- An apparatus as claimed in claim 5 wherein the shaft comprises a tube.
- An apparatus as claimed in claim 5 or 6 wherein each of the first and second regions comprises a groove (445, 446, 455, 456).
- An apparatus as claimed in any preceding claim in which further comprises:a needle (460) having a distal region and a proximal region, the distal region being defined between two holding elements.
- An apparatus as claimed in claim 8 in which the first fixation member (16) is positioned within the distal region before fixation on tissue and the second fixation member (18) is positioned within the proximal region before fixation on tissue.
- An apparatus as claimed in either claim 8 or 9 wherein one of the holding elements comprises a crimp in the needle in the distal region.
- An apparatus as claimed in any one of claims 8, 9 or 10 wherein one of the holding elements comprises a dimple extending into a lumen of the needle.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/704,926 US7153312B1 (en) | 1999-12-02 | 2000-11-02 | Closure device and method for tissue repair |
US704926 | 2000-11-02 | ||
PCT/US2001/032625 WO2002036020A1 (en) | 2000-11-02 | 2001-10-24 | Closure device and method for tissue repair |
Publications (2)
Publication Number | Publication Date |
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EP1331886A1 EP1331886A1 (en) | 2003-08-06 |
EP1331886B1 true EP1331886B1 (en) | 2008-12-17 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP01981796A Expired - Lifetime EP1331886B1 (en) | 2000-11-02 | 2001-10-24 | Closure device for tissue repair |
Country Status (7)
Country | Link |
---|---|
EP (1) | EP1331886B1 (en) |
JP (1) | JP4160386B2 (en) |
AT (1) | ATE417550T1 (en) |
AU (1) | AU2002213414A1 (en) |
CA (1) | CA2427528A1 (en) |
DE (1) | DE60137070D1 (en) |
WO (1) | WO2002036020A1 (en) |
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- 2001-10-24 DE DE60137070T patent/DE60137070D1/en not_active Expired - Lifetime
- 2001-10-24 AT AT01981796T patent/ATE417550T1/en not_active IP Right Cessation
- 2001-10-24 JP JP2002538834A patent/JP4160386B2/en not_active Expired - Fee Related
- 2001-10-24 AU AU2002213414A patent/AU2002213414A1/en not_active Abandoned
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Also Published As
Publication number | Publication date |
---|---|
DE60137070D1 (en) | 2009-01-29 |
JP4160386B2 (en) | 2008-10-01 |
EP1331886A1 (en) | 2003-08-06 |
JP2004515273A (en) | 2004-05-27 |
WO2002036020A1 (en) | 2002-05-10 |
WO2002036020A9 (en) | 2003-02-13 |
AU2002213414A1 (en) | 2002-05-15 |
ATE417550T1 (en) | 2009-01-15 |
CA2427528A1 (en) | 2002-05-10 |
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